Section 12 Dot/Forest plot used in BRAT framework

Forest plot from BRAT framework
Short name Description
Name/rubric Forest plot on absolute risks
Created in BRAT Excel Tool adapted in PowerPoint, but could also be done in PowerPoint alone.
Message It shows the risk difference between natalizumab and placebo at time of CHMP re-evaluation on individual key benefits and risks criteria. The forest plot leads to judgement of positive benefit risk balance. Absolute numbers as presented are more supportive to allow judgements when compared to relative values. Statistical uncertainty of the risk difference is also given. The forest plot is a simple visual graph, and is easier to comprehend when compared to a table with the same information..
Intended audience Statisticians, Physicians, Regulators; not for patients
Knowledge required Needs medical knowledge, low statistical knowledge.
Unintentional message Risk of very small but important events may be undervalued.
Message not communicated The weights appeared with criteria name are confusing since it is unclear how they are to be taken into account in this graph. Convenience and Congenital abnormalities criteria appear on the forest plot but are not quantified. In general, non-categorical values are difficult to capture i.e. 6 min walk test, time aspect not covered as for example in Kaplan Mayer curves.
Proposed improvement Replace higher by favours if the latter can correctly describe the direction, or otherwise describe whether higher is desirable or undesirable outcome. Use green and red instead of blue and yellow with clearer text colours (black is likely to be the most visible here). The plot could have dual horizontal axis to represent both continuous and categorical outcomes. A second graph can be added where weights have been incorporated into the measure of differences.